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DESVENLAFAXINE ACTAVIS Modified Release Tablets

Consumer Medicine Information

WHAT IS IN THIS Ask your doctor if you have any Do not take Desvenlafaxine Actavis LEAFLET questions about why if you are allergic to Desvenlafaxine Actavis has been desvenlafaxine, or to prescribed for you. any of the ingredients listed at the This leaflet answers some common Your doctor may have prescribed it end of this leaflet. questions about Desvenlafaxine for another reason. Actavis. Symptoms of an allergic reaction include: It does not contain all the available How it works • information. It does not take the Skin rash place of talking to your doctor or Desvenlafaxine Actavis contains the • Itching or hives on the skin pharmacist or asking questions. active ingredient called • Swelling of the face, lips, tongue, desvenlafaxine. It belongs to a class All medicines have risks and throat or other parts of the body of medications called - benefits. Your doctor has weighed • , wheezing, Noradrenaline Inhibitors the risks of you taking troubled breathing or difficulty (SNRIs). Desvenlafaxine Actavis against the swallowing. expected benefits it will have for Serotonin and noradrenaline are Do not give Desvenlafaxine Actavis you. chemical messengers that allow to children or adolescents under 18 certain nerves in the brain to work. years of age. If you have any questions about Desvenlafaxine Actavis tablets The safety and effectiveness of Desvenlafaxine Actavis, ask your doctor or pharmacist. increase the level of these two desvenlafaxine in this age group have messengers. Experts think this is how not been established. Keep this leaflet with your it helps to restore your feeling of Do not take this medicine after the Desvenlafaxine Actavis tablets. wellness. You may need to read it again. expiry date (EXP) printed on the Desvenlafaxine Actavis is not pack, or if the packaging is torn or addictive. It is available only with a shows signs of tampering. doctor's prescription. If it has expired or is damaged, return it to your pharmacist for disposal. What Desvenlafaxine Actavis is used for If you are not sure whether you should start taking this medicine, Before you take talk to your doctor. What it does Desvenlafaxine Actavis Before you start to take it Desvenlafaxine is used in the treatment and prevention of relapse When you must not take it Tell your doctor or pharmacist if of depression. Depression can affect you have allergies to any other your whole body and may cause Do not take Desvenlafaxine Actavis medicines, foods, preservatives or emotional and physical symptoms if you are taking other medications dyes. for depression known as such as feeling low in spirit, being monoamine oxidase inhibitors, unable to enjoy life, poor or even if you have stopped taking overeating, disturbed sleep, loss of them, but have taken them within sex drive, lack of energy and feeling the last 14 days. guilty over nothing.

DESVENLAFAXINE ACTAVIS Published by MIMS July 2015 1 Tell your doctor or pharmacist if • all medicines, vitamins, herbal You may need to take different you are pregnant or intend to supplements or natural therapies amounts of your medicine, or you become pregnant. you buy without a prescription may need to take different medicines. Desvenlafaxine Actavis is not from a pharmacy, supermarket, Your doctor will advise you. recommended for use during naturopath or health food shop, Your doctor or pharmacist has more . Your doctor will discuss such as St John's Wort or information on medicines to be the risks and benefits of taking supplements. careful with or to avoid while taking desvenlafaxine if you are pregnant. Do not start to take any other One of these risks is that newborn Desvenlafaxine Actavis. medicine while you are taking babies whose mothers have been Desvenlafaxine Actavis, unless it is Switching to Desvenlafaxine taking desvenlafaxine may have prescribed or approved by your several problems including breathing doctor. Actavis from other difficulties, and lack of oxygen in their blood. Some medicines may interfere with desvenlafaxine or desvenlafaxine Side effects from discontinuing Tell your doctor or pharmacist if may interfere with these medicines. medication may occur you are breast-feeding or plan to These include: if you are switched from other breast-feed. • medications for depression antidepressants, including Desvenlafaxine passes into breast known as monoamine oxidase venlafaxine, to Desvenlafaxine milk and there is a possibility that the inhibitors (MAOIs) (such as Actavis. Your doctor may gradually breast-fed baby may be affected. For , and reduce the dose of your initial this reason, the use of desvenlafaxine ). Tell your antidepressant medication to help is not recommended in breast-feeding doctor if you are taking or have reduce these side effects. women. stopped taking them within the Tell your doctor if you have, or last 14 days. Ask your doctor or have had, any medical conditions, pharmacist if you are unsure if especially the following: you are taking any of these How to take • a history of fits (seizures or medicines. It is important that Desvenlafaxine Actavis convulsions) you do not take Desvenlafaxine • a personal history or family Actavis or medicines similar to Follow all directions given to you history of bipolar disorder Desvenlafaxine Actavis with by your doctor or pharmacist carefully. • problems MAOIs or within 14 days of taking an MAOI as this may They may differ from the • (increased pressure in result in a serious life-threatening information contained in this leaflet. the eye) condition. Your doctor or • a tendency to bleed more than If you do not understand the pharmacist can tell you what to normal or you are taking a blood instructions on the box, ask your do if you are taking any of these doctor or pharmacist for help. thinning medication medicines. • raised cholesterol or lipid levels • any other medications for bipolar • How to take it problems with your kidneys or disorder, depression, , obsessive-compulsive disorder or Swallow the tablets whole with a • problems with your heart pre-menstrual dysphoric disorder, glass of or other non- • low sodium levels in your blood including St John's Wort alcoholic liquid. • any other medical conditions. • drugs that affect serotonin levels Do not divide, crush, chew or place e.g. , , Tell your doctor if you plan to have the tablets in water. surgery. If you have not told your fentanyl, and doctor about any of the above, tell pentazocine them before you start to take • medicines for , Desvenlafaxine Actavis. including • (used to treat ) Taking other medicines • (used to treat infections) • drugs that affect your tendency to Tell your doctor or pharmacist if you take any other medicines, bleed e.g. aspirin, NSAIDS, including: warfarin. • all prescription medicines

DESVENLAFAXINE ACTAVIS Published by MIMS July 2015 2 Do not be concerned if you see a If you forget to take it Keep enough Desvenlafaxine tablet 'shell' in your faeces after Actavis tablets to last weekends taking Desvenlafaxine Actavis. If it is less than 12 hours until your and holidays. As the tablet travels the length of next dose, skip the dose you missed This medicine helps to control your your , the active and then take your next dose when condition, but does not cure it. It is ingredient desvenlafaxine is slowly you are meant to. Otherwise, take important to keep taking your it as soon as you remember, and released. The tablet 'shell' remains medicine even if you feel well. then go back to taking as you undissolved and is eliminated in your would normally. Watch carefully for signs that your faeces. Therefore, even though, you depression is getting worse, Do not take a double dose to make may see a tablet 'shell' in your faeces, especially in the first few weeks of up for the dose you missed. your dose of desvenlafaxine has been treatment or if your dose has absorbed. This may increase the chance of you changed. getting an unwanted side effect. Sometimes people with depression How much to take If you are not sure what to do, ask can experience a worsening of their your doctor or pharmacist. If you depressive symptoms. This can The usual dose is 50 mg taken once have trouble remembering when to happen even when taking an daily with or without food. take your medicine, ask your antidepressant. pharmacist for some hints. Do not change your dose unless Tell your doctor there is the potential your doctor tells you to. for a false positive urinary drug Your doctor will gradually increase If you take too much screen while on Desvenlafaxine your dose if needed. If you have (overdose) Actavis. kidney problems, you may need a lower dose of Desvenlafaxine Immediately telephone your doctor Tell your doctor immediately if Actavis. or the Poisons Information Centre you experience any of the following (tel: 13 11 26) for advice, or go to symptoms, especially if they are Accident and Emergency at your severe, you have not had these When to take it nearest hospital if you think that symptoms before or they happen you or anyone else may have taken very suddenly. Desvenlafaxine Actavis should be too much Desvenlafaxine Actavis. taken once daily and can be taken • anxiety or agitation with or without food. Do this even if there are no signs of • panic attacks discomfort or poisoning. • Take Desvenlafaxine Actavis at difficulty sleeping You may need urgent medical approximately the same time each • irritability attention. day. • aggressiveness This could be either in the morning Keep the telephone number for • hostility or impulsiveness or in the evening. Taking it at the these places handy whilst taking • restlessness same time each day will have the any medications. • best effect. It will also help you overactivity or uninhibited remember when to take it. behaviour • other unusual changes in How long to take it While you are taking behaviour Desvenlafaxine Actavis • thoughts of . Continue taking your medicine for Tell your doctor immediately if as long as your doctor tells you. you have any thoughts about Although you may begin to feel Things you must do suicide or doing harm to yourself. better after two weeks, it may take several weeks before you feel much Visit your doctor regularly for a Warning signs of suicide better. It is important to give check up so that your progress can be checked. Always discuss any Desvenlafaxine Actavis time to If you or someone you know is questions you have about work. showing the following warning Desvenlafaxine Actavis with your signs, contact your doctor or a This medicine helps to control your doctor. mental health advisor right away condition, so it is important to keep Take Desvenlafaxine Actavis or go to the nearest hospital for taking your medicine even if you feel tablets as your doctor has treatment. well. prescribed. Tell any other doctors, All thoughts or talk about suicide or dentists and pharmacists who treat violence are serious. you that you are taking this medicine.

DESVENLAFAXINE ACTAVIS Published by MIMS July 2015 3 • thoughts or talk about death or SIDE EFFECTS • difficulty thinking or working suicide because of: • thoughts or talk about self-harm Tell your doctor or pharmacist as - yawning or doing harm to others soon as possible if you do not feel - disturbances in concentration • any recent attempts of self-harm well while you are taking - fainting or dizziness after Desvenlafaxine Actavis. standing up • an increase in aggressive All medicines can have side effects. - fatigue -Rapid heart beat behaviour, irritability or agitation. Sometimes they are serious; often - chills they are not. You may need medical - headache Things to be careful of attention if you get some of the side • changes in your appearance: Be careful driving or operating effects. - excessive sweating dangerous machinery until you It can be difficult to tell whether side - hot flushes know how Desvenlafaxine Actavis effects are the result of taking this - rash affects you. medicine, symptoms of your - weight loss or weight gain Desvenlafaxine Actavis tablets may condition, or side effects of other • blurred vision make you feel drowsy. medicines you may be taking. For • ringing in the ears this reason it is important to tell your • altered taste, dry mouth. Things you must not do doctor of any change in your condition. Do not stop taking Desvenlafaxine Tell your doctor as soon as Actavis or change the dose without Do not be alarmed by the list of possible if... the advice of your doctor, even if side effects. you feel better. You may not experience any of them. Tell your doctor as soon as possible Your doctor may want to slowly if you notice any of the following: Ask your doctor or pharmacist to decrease your dose of • muscle stiffness, weakness or answer any questions you may Desvenlafaxine Actavis to help avoid have. movement disorders side effects. Side effects are known • abnormal facial movements such to occur when people stop taking as tongue thrusting, repetitive Tell your doctor if... Desvenlafaxine Actavis, especially chewing, jaw swinging, or when they suddenly stop therapy. Tell your doctor or pharmacist if grimacing Some of these side effects include: you notice any of the following and • a feeling of apathy or not caring they worry you: • headache about things • stomach, bowel or urinary tract • • feeling detached from yourself problems: • • dizziness hallucinations, confusion - nausea or vomiting • bleeding or bruising more easily • tiredness - loss of appetite than normal • irritability - diarrhoea • numbness or pins and needles. • anxiety - constipation • abnormal dreams - difficulty passing urine Go to hospital if... • diarrhoea • changes in your behaviour: • excessive sweating. - difficulty sleeping, abnormal Tell your doctor immediately, or sleepiness or abnormal dreams go to Accident and Emergency at Slowly reducing the amount of - sexual function problems such your nearest hospital if you notice Desvenlafaxine Actavis being taken as decreased sex drive, delayed any of the following: reduces the possibility of these ejaculation, problems achieving • swelling of the face, lips, tongue, effects occurring. erection or difficulties achieving throat or other parts of the body Some of these symptoms may orgasm • seizures or fits impair driving, or the operation of - nervousness or anxiety • symptoms of sudden with dangerous machinery. Avoid these - feeling jittery or irritable activities if you experience any of sweating, rapid heartbeat and these symptoms. muscle stiffness, which may lead to loss of consciousness. Avoid drinking alcohol while you are taking Desvenlafaxine Actavis. Do not give this medicine to anyone else even if they have the same condition as you.

DESVENLAFAXINE ACTAVIS Published by MIMS July 2015 4 Tell your doctor or pharmacist if Disposal The 50 mg tablets are film coated you notice anything else that is with OPADRY film coating system making you feel unwell. If your doctor tells you to stop 03F84770 PINK (ARTG No. taking this medicine or the expiry Other side effects not listed above 109228) and the 100 mg tablets are date has passed, ask your may also occur in some people. coated with OPADRY film coating Some of these side effects (for pharmacist what to do with any medicine that is left over. system 03F86990 BROWN (ARTG example, increase in blood pressure, No. 109232). increase in blood cholesterol, changes to liver function, protein in Supplier the urine) can only be found when your doctor does tests from time to PRODUCT Desvenlafaxine Actavis tablets are time to check your progress. DESCRIPTION supplied by: This is not a complete list of all Actavis Pty Ltd 117 Harrington Street possible side effects. Others may What Desvenlafaxine Actavis occur in some people and there may THE ROCKS looks like be some side effects not yet known. NSW 2000 There are two strengths of Tell your doctor if you notice Australian Registration anything that is making you feel Desvenlafaxine Actavis tablets: unwell. • 50 mg, light pink coloured, Numbers diamond shaped, biconvex Bottles* tablets, debossed with 'L189' on • one side and plain on other side. Desvenlafaxine Actavis 50 mg After taking Blister packs and bottles modified release tablets: containing 7, 14 or 28 tablets*. AUST R 218070 Desvenlafaxine Actavis • • 100 mg, dark brown to red Desvenlafaxine Actavis 100 mg coloured, diamond shaped, modified release tablets: Storage biconvex tablets, debossed with AUST R 218078 'L190' on one side and plain on Blister packs Keep your Desvenlafaxine Actavis other side. Blister packs and • tablets in their blister pack until it Desvenlafaxine Actavis 50 mg bottles containing 7, 14 or 28 is time to take them. modified release tablets: tablets*. The tablets may not last as well if AUST R 218064 you take them out of the blister pack. *Not all pack sizes are available in • Desvenlafaxine Actavis 100 mg . modified release tablets: Keep Desvenlafaxine Actavis AUST R 218071 tablets in a cool dry place where the temperature stays below 25°C. Ingredients * Not marketed in Australia. Do not store Desvenlafaxine Desvenlafaxine Actavis tablets Actavis tablets or any other contain 50 mg or 100 mg Date of Preparation medicine in the bathroom or near a desvenlafaxine as the active This leaflet was last revised in sink. Do not leave Desvenlafaxine ingredient. February 2015. Actavis tablets in the car or on windowsills. It also contains the following inactive Heat and dampness can destroy some ingredients: medicines. • alginic acid • citric acid monohydrate Keep Desvenlafaxine Actavis tablets and all medication where • microcrystalline cellulose young children cannot reach it. • povidone A locked cupboard, at least one-and- • talc a-half metres above the ground, is a • magnesium stearate good place to store medicines. • hypromellose.

DESVENLAFAXINE ACTAVIS Published by MIMS July 2015 5